Novartis receives FDA approval of Menveo

BASEL, Switzerland — The U.S. Food and Drug Administration approved Novartis’ Menveo to prevent meningococcal disease, which infects more than 500,000 people each year, leading to more than 50,000 deaths globally.

"The FDA approval of Menveo is an important milestone for adolescent immunization in the United States. According to CDC estimates, approximately 16 million adolescents between the ages of 11 and 18 are at risk and remain unprotected against meningococcal disease," said Andrin Oswald, division head of Novartis Vaccines and Diagnostics. "Meningococcal disease is particularly distressing because it can rapidly kill or debilitate previously healthy adolescents. For this reason, we are dedicated to helping eradicate meningococcal disease in the United States and around the world."

As many as one in seven people who contract meningococcal disease die from it. Approximately one in five meningococcal disease survivors suffer serious, permanent and devastating side effects, including limb amputations, seizures, paralysis, hearing loss and learning disabilities.

Meningococcal disease is a leading cause of bacterial meningitis, which is an infection of the membrane around the brain and spinal cord, and sepsis, an often life-threatening bloodstream infection. Even with early and appropriate treatment, the disease may progress rapidly and is potentially fatal, often within 24 to 48 hours of onset of symptoms.

In the United States, incidence of meningococcal disease varies, ranging between 1,000 and 3,000 cases per year.